Merc provides assistance with all activities related to the management of Clinical Studies:
- Selection of study sites and Investigators, definition of financial agreements.
- Protocol and CRF design, in collaboration with the PI.
- SOP definition and implementation in compliance with Regulatory requirements (ISO 14155 standards and Good Clinical Practice requirements).
- Management of administrative issues (contacts with Authorities, insurance policies, document translation , budget control, etc.)
- Reporting of adverse events.
- Training of all participants (Investigators and Sites) and the GCP, in order to ensure compliance with Regulations.
- Keeping investigators and sites up-to-date with the status and progress of the study.